RenalytixAI soars as FDA OK's emergency use of Kantaro COVID antibody test

 

• Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI (NASDAQ:RNLX), has received Emergency Use Authorization (EUA) from the FDA for COVID-SeroKlir, its semi-quantitative SARS-CoV-2 IgG antibody test kit.
• Unlike other antibody tests, COVID-SeroKlir determines the presence and precise level of IgG antibodies and has a broad range of applications in COVID-19.
• COVID-SeroKlir has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain.
• Through a commercial partnership with Bio-Techne Corporation (NASDAQ:TECH) the test kits are being manufactured at scale with a capacity of up to 10M tests per month and the ability to scale up.
• The Kantaro test kit received CE mark in October 2020 and is available in 29 European countries.
• https://seekingalpha.com/news/3639385-renalytixai-soars-20-fda-oks-emergency-use-of-kantaros-covidminus-19-antibody-test